Optimisation and validation of liquid chromatographic and partial least-squares-1 methods for simultaneous determination of enalapril maleate and nitrendipine in pharmaceutical preparations

被引:5
作者
Caglayan, Mehmet Gokhan [1 ]
Palabiyik, Ismail Murat [1 ]
Bor, Mustafa [1 ]
Onur, Feyyaz [1 ]
机构
[1] Ankara Univ, Dept Analyt Chem, Fac Pharm, TR-06100 Ankara, Turkey
关键词
enalapril maleate; nitrendipine; liquid chromatography; spectrophotometry; optimisation; validation; SPECTROPHOTOMETRIC DETERMINATION; VALERATE;
D O I
10.2478/s11696-011-0078-2
中图分类号
O6 [化学];
学科分类号
0703 ;
摘要
Simultaneous determination of enalapril maleate (ENA) and nitrendipine (NIT) in pharmaceutical preparations was performed using liquid chromatography (LC) and the partial least-squares-1 (PLS-1) method. In LC, the separation was achieved on a C8 column and the optimum mobile phase for good separation in a gradient elution programme was found to be acetonitrile-water (phi(r) = 81 : 19) and optimum flow-rate, temperature, injection volume, and detection wavelength were set at 1.0 mL min(-1), 25 degrees C, 10 mu L, and 210 nm, respectively. Dienogest was selected as an internal standard. In the spectrophotometry, a PLS-1 chemometric method was used. The absorbance data matrix related to the concentration data matrix was established by measurement of absorbances in their zero order spectra with an increment of Delta gimel = 1 nm in the 220-290 nm range for ENA and with Delta gimel = 1 nm in the 230-290 nm range for NIT in the PLS-1 method. Following this step, calibration was established by using this data matrix to predict the unknown concentrations of ENA and NIT in their binary mixture. These optimised methods were validated and successfully applied to a pharmaceutical preparation in tablet form and the results were subjected to comparison. (C) 2011 Institute of Chemistry, Slovak Academy of Sciences
引用
收藏
页码:754 / 760
页数:7
相关论文
共 10 条
[1]  
Brereton R.G., 2002, Chemometrics: Data Anaylsis for the Laboratory and the Chemical Plant
[2]  
Çaglayan MG, 2010, J AOAC INT, V93, P862
[3]   NITRENDIPINE - A REVIEW OF ITS PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES, AND THERAPEUTIC EFFICACY IN THE TREATMENT OF HYPERTENSION [J].
GOA, KL ;
SORKIN, EM .
DRUGS, 1987, 33 (02) :123-155
[4]  
International Conference on Harmonization. Q1A ICH, 2003, INT C HARM TECHN REQ
[5]   Quantitative analysis of mixed hydrofluoric and nitric acids using Raman spectroscopy with partial least squares regression [J].
Kang, Gumin ;
Lee, Kwangchil ;
Park, Haesung ;
Lee, Jinho ;
Jung, Youngjean ;
Kim, Kyoungsik ;
Son, Boongho ;
Park, Hyoungkuk .
TALANTA, 2010, 81 (4-5) :1413-1417
[6]  
Karacan E, 2011, J AOAC INT, V94, P128
[7]   EFFECT OF ENALAPRILAT ON BRADYKININ AND DES-ARG(9)-BRADYKININ RELEASE FOLLOWING REPERFUSION OF THE ISCHEMIC RAT-HEART [J].
LAMONTAGNE, D ;
NADEAU, R ;
ADAM, A .
BRITISH JOURNAL OF PHARMACOLOGY, 1995, 115 (03) :476-478
[8]  
Palabiyik IM, 2008, QUIM NOVA, V31, P1121, DOI 10.1590/S0100-40422008000500035
[9]   Effect of angiotensin converting enzyme inhibitor enalapril on body weight and composition in young rats [J].
Santos, Edson L. ;
Souza, Kely de Picoli ;
Guimaraes, Paola Bianchi ;
Reis, Felipe Castellani Gomes ;
Silva, Sylvia Maria Affonso ;
Costa-Neto, Claudio M. ;
Luz, Jacqueline ;
Pesquero, Joao B. .
INTERNATIONAL IMMUNOPHARMACOLOGY, 2008, 8 (02) :247-253
[10]   Chemometric methods for simultaneous quantification of lactic, malic and fumaric acids [J].
Sokullu, Esen ;
Palabiyik, Ismail Murat ;
Onur, Feyyaz ;
Boyaci, Ismail Hakki .
ENGINEERING IN LIFE SCIENCES, 2010, 10 (04) :297-303